FDA 510(k)

SIMPLICITY DISPOSABLE PEN NEEDLE

K-Number: K002180 · 2000-10-13

Decision Date2000-10-13

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SIMPLICITY DISPOSABLE PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Medivations, Inc.. It received FDA 510(k) clearance on 2000-10-13 under 510(k) number K002180. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLICITY DISPOSABLE PEN NEEDLE?

SIMPLICITY DISPOSABLE PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2000-10-13. The listed applicant is Sterling Medivations, Inc.. The 510(k) number is K002180.

When did SIMPLICITY DISPOSABLE PEN NEEDLE receive FDA 510(k) clearance?

SIMPLICITY DISPOSABLE PEN NEEDLE received FDA 510(k) clearance on 2000-10-13, under 510(k) number K002180.

Who is the listed applicant for SIMPLICITY DISPOSABLE PEN NEEDLE?

The FDA 510(k) record lists Sterling Medivations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLICITY DISPOSABLE PEN NEEDLE?

The FDA product code for SIMPLICITY DISPOSABLE PEN NEEDLE is FMI.

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Other records listing Sterling Medivations, Inc. as applicant

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Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.